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Clinical Trials/NCT04306107
NCT04306107
Unknown
Not Applicable

Prone Position in Non-Invasive Ventilation and High-Flow Oxygen Therapy

Hospital General Universitario Morales Meseguer0 sites100 target enrollmentSeptember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Evaluation of Prone Position Effect During NIV and HFNC on Acute Hypoxemic Respiratory Failure
Sponsor
Hospital General Universitario Morales Meseguer
Enrollment
100
Primary Endpoint
Oro-tracheal entubation
Last Updated
4 years ago

Overview

Brief Summary

The aim of this trial is to study the effect of prone position during NIV and HFNC on acute hypoxemic respiratory patients.

Detailed Description

Inclusion Criteria: Adult patients with: • ARDS/pneumonia/acute hypoxemic respiratory failure with PaO2/FiO2 between 150 and 300 (on 5 cmH2O PEEP level) Exclusion Criteria * General NIV or HFNC contraindications * Immediate need for IOT * Prone position intolerance * Patients refusal to participate Interventions: * Prone position for 2-4 hours twice a day, for 3 days (first 3 days since admission to ICU) * Nurse surveilance: at least every 15 minutes Outcomes: * Need for IOT * Effects on the measurements specified above (particularly PaO2/FiO2)

Registry
clinicaltrials.gov
Start Date
September 1, 2021
End Date
May 1, 2022
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hospital General Universitario Morales Meseguer
Responsible Party
Principal Investigator
Principal Investigator

Miguel Filipe Martins de Matos Navarro Guia

MD

Hospital General Universitario Morales Meseguer

Eligibility Criteria

Inclusion Criteria

  • Adult patients with:
  • ARDS/pneumonia/acute hypoxemic respiratory failure with PaO2/FiO2 between 150 and 300 (on 5 cmH2O PEEP level)

Exclusion Criteria

  • General NIV or HFNC contraindications
  • Immediate need for IOT
  • Prone position intolerance
  • Patients refusal to participate

Outcomes

Primary Outcomes

Oro-tracheal entubation

Time Frame: 1 month

Oro-tracheal entubation avoidance

Secondary Outcomes

  • PaO2/FiO2(1 month)

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